Clinical trial · Observational

Evaluating a New Gonadotoxic Risk Stratification System

NCT05052632CI-TRIAL-00093562withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Cancelled by PI

Summary

Brief summary (as posted)

The primary objective of this study is to assess if there is an association between a newly described gonadotoxic risk stratification system and post-treatment ovarian reserve as determined by FSH and AMH.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Ovarian reserve
timeFrame
2 year follow up
description
The Investigator will evaluate if there is an association between ovarian reserve (defined using AMH and FSH) and the risk stratification system categories (minimally increased risk, significantly increased risk, and high level of increased risk). Specifically Ovarian reserve goes from normal (\[FSH \<10\] AND \[AMH \>= 1.0\]), Diminished ovarian reserve (\[10 \<=FSH \< 25\] or \[ 0.5 \<= AMH \<1.0\]), primary ovarian insufficiency (\[25\<= FSH\] or \[ 0.5 \< AMH\]). AMH: ng/ml, FSH: mIU/ml. Investigator will test the amount of agreement between the two ordinal variables using a kappa statistic at each time point in the first two years of follow-up. Investigator will perform ordinal logistic regression accounting for repeated measures for participants who are not using contraception. Investigator will access patient characteristics to see if Investigator need to adjust for other covariates including age, race, ethnicity, and body mass index.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 8 Years
Maximum age: 39 Years

Show eligibility criteria text

Inclusion Criteria:

* Female patients ages 8 - 39 years of age
* Seen in CHCO or AMC outpatient clinics for any of the following reasons:

  * At risk for fertility problems (Z91.89)
  * Encounter for fertility preservation counseling (Z31.62)
  * Primary ovarian insufficiency
  * Premature ovarian failure/premature menopause
  * Diminished ovarian reserve
* At least 12 months post-completion of chemotherapy and/or radiation
* History of a fertility-threatening diagnosis receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy, including but not limited to:

  * Any type of cancer/malignancy
  * Rheumatoid arthritis
  * Systemic lupus erythematosus
  * Aplastic anemia
  * Fanconi anemia
  * Diamond-Blackfan syndrome
  * Hurler syndrome
  * Other autoimmune conditions

Exclusion Criteria:

* Disorders of sexual development (i.e., gonadal dysgenesis, Turner syndrome/mosaicism, etc.)
* History of bilateral oophorectomy
* Transgender patients not receiving chemotherapy; radiation; or surgery to the reproductive organs for malignancy
* Inability to consent/assent

References

Publications (0)

Data not yet available

No reference posted for this study.